The Business Research Company’s 2026 market reports include new capabilities such as market attractiveness scoring and analysis, total addressable market analysis, company scoring matrix, interactive excel data dashboard, improved supply chain analysis, upcoming startups in the market, and overview of key products, aimed at improving the depth, usability, and strategic value of the insights delivered.
What Is The Expected Market Size Of The Software As A Medical Device (SaMD) Market From 2026 To 2030?
The software as a medical device (samd) market has observed substantial expansion in recent years. It is anticipated to increase from $38.02 billion in 2025 to $47.26 billion in 2026, at a compound annual growth rate (CAGR) of 24.3%. The historic growth of this market can be attributed to the rise in telemedicine adoption, increased smartphone penetration, digital health funding, improved regulatory clarity, and the growing demand for remote care.
The software as a medical device (samd) market size is anticipated to experience substantial growth over the coming years. This market is projected to reach $120.54 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 26.4%. Factors contributing to this growth during the forecast period encompass the expansion of virtual care, advancements in software-driven diagnostics, the rise of cloud healthcare platforms, the shift towards outcome-based reimbursement, and the modernization of hospital software. Key trends observed throughout this period are expected to include the broadening of clinical decision support software, an increase in remote diagnostic applications, enhanced regulatory validation for medical software, the adoption of subscription-based samd business models, and integration with electronic health records.
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What Key Drivers Are Influencing The Growth Of The Software As A Medical Device (SaMD) Market?
The expansion of the software as a medical device (SaMD) market is anticipated to be fueled by the rising occurrence of chronic diseases. These enduring health conditions, such as diabetes, heart disease, and arthritis, typically advance gradually and necessitate continuous medical care and lifestyle adjustments for symptom control and complication prevention. Their increasing prevalence is largely attributed to unhealthy lifestyle choices like poor diet, lack of physical activity, and smoking, which heighten the likelihood of developing such conditions. Software as a medical device (SaMD) facilitates the management of chronic diseases through continuous patient health metric monitoring, enabling early identification of potential complications. It further enhances treatment results by offering tailored insights and supporting remote care, thereby decreasing the necessity for frequent hospital attendance. For instance, data from June 2024 by the National Health Service, a UK-based government department, revealed that 3,615,330 individuals registered with a general practitioner (GP) were diagnosed with non-diabetic hyperglycemia or pre-diabetes (a condition with elevated blood sugar levels, not high enough to be classified as diabetes) in 2023. This represented an 18% surge from 3,065,825 cases recorded in 2022. Consequently, the expanding occurrence of chronic diseases is a primary catalyst for the growth in the software as a medical device (SaMD) market.
Which Segments Are Included In The Analysis Of The Software As A Medical Device (SaMD) Market?
The software as a medical device (samd) market covered in this report is segmented –
1) By Device Type: Wearable Device, PCs And Laptop, Smartphone And Tablets
2) By Deployment Method: Cloud-Based, On-Premise
3) By Application: Diagnostic, Clinical Management
Subsegments:
1) By Wearable Devices: Smartwatches With Health Monitoring Functions, Fitness Trackers, Wearable ECG And Blood Pressure Monitors
2) By PCs And Laptops: Medical Diagnostic Software, Clinical Decision Support Software, Telemedicine Platforms
3) By Smartphone And Tablets: Mobile Health (mHealth) Apps, Remote Patient Monitoring Software, Diagnostic Imaging Apps
Which Trends Are Impacting The Growth Of The Software As A Medical Device (SaMD) Market?
Leading companies in the software as a medical device (SaMD) market are intensifying their efforts to launch sophisticated software, such as SOMNUM, to gain a market advantage. SOMNUM is a sleep disease analysis software that combines the latest AI research trends with diagnostic algorithms, relying on multi-channel sleep biosignal data rather than video images. For example, in September 2023, HoneyNaps Co. Ltd., a South Korea-based software entity, secured approval from the United States Food and Drug Administration (USFDA) for its SOMNUM software. This software leverages deep learning-based AI to conduct real-time analysis of various sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. The software is engineered to provide more accurate and refined readings than conventional methods, capable of shortening the analysis of patient sleep data to under five minutes.
Which Key Industry Participants Are Active In The Software As A Medical Device (SaMD) Market?
Major companies operating in the software as a medical device (samd) market are Apple Inc., Abbott Laboratories, Siemens Healthcare GmbH, GE HealthCare Technologies Inc., Roche Diagnostics, Cerner Corporation, Philips Medical Systems Ltd., Dexcom Inc., Carl Zeiss Meditec AG, Nihon Kohden Corporation, Viz.ai Inc., S3 Connected Health, Arterys Inc., BrightInsight Inc., Agfa HealthCare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.
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Which Region Is Expected To Register The Fastest Growth In The Software As A Medical Device (SaMD) Market?
North America was the largest region in the software as a medical device (SaMD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the software as a medical device (samd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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